Investigation of Cerebral Motor Activity Modulations Following Median Nerve Stimulation During General Anaesthesia

NCT ID: NCT05272202

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2026-12-31

Brief Summary

Accidental Awareness during General Anesthesia (AAGA) occurs in 1-2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). Actually, no monitoring techniques can accurately predict or detect an AAGA. Since the first reflex for a patient during an AAGA is to move, a brain-computer interface (BCI) based on the detection of an intention of movement would be conceivable to alert the anesthetist. The investigators previously showed that median nerve stimulation (MNS) could be the keystone of a BCI specialized in the detection of movement intention. Indeed, based on these previous results, the investigators can envisage a routine system where the patient would be stimulated at the median nerve position, while a BCI device would analyze the event-related desynchronization (ERD) and event-related synchronization (ERS) modulations in the motor cortex to check whether the patient is intending to move or not. According to the investigator's knowledge, no published studies have investigated the detection of EEG patterns in relation to peripheral nerve stimulation over the sensorimotor cortex during general anesthesia. The main objective of this study is to describe the changes in terms of ERD and ERS modulations, in the EEG signal over the motor cortex, during general anesthesia with propofol, while a median nerve stimulation is performed.

STIM-MOTANA is an interventional and prospective study conducted in patients scheduled for surgery under general anesthesia, involving EEG measurements and median nerve stimulation. In this study, 30 patients will undergo surgery under total intravenous anesthesia using a propofol target-controlled infusion pump. The rest of the anesthetic protocol will be at the discretion of the anesthesiologist in charge. Changes in ERD and ERS during median nerve stimulation according to the various propofol concentrations will be continuously monitored by an EEG amplifier. Pre- and post-injection comparisons of propofol will be performed by paired series tests. After surgery, patients will have a gradual decrease of propofol at different effect-site concentrations (from 4.0 μg/ml to 2.0 μg/ml, in increments of 0.5 μg/ml).

Conditions

Accidental Awareness During General Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Median nerve stimulation

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

STIM-MOTANA is an interventional and prospective study conducted in patients scheduled for surgery under general anesthesia, involving EEG measurements and median nerve stimulation. In this study, 30 patients will undergo surgery under total intravenous anesthesia using a propofol target-controlled infusion pump. The rest of the anesthetic protocol will be at the discretion of the anesthesiologist in charge. After surgery, patients will have a gradual decrease of propofol at different effect-site concentrations (from 4.0 μg/ml to 2.0 μg/ml, in increments of 0.5 μg/ml).

Median nerve stimulation

Intervention Type: DEVICE

The right-hand median nerve will be stimulated in the same way as for measurement with a conduction velocity or for an evoked potential. Two stimulation electrodes will be placed on the right-hand wrist according to the standards.The stimulation is transcutaneous and painless using the specific Micromed device Sd Ltm Stim Energy (Micromed, Mˆacon, France). The stimulus intensity will range between 3 and 14 mA. The stimulation duration will be 100 ms with a frequency of 0.1 Hz.

EEG measurements

Intervention Type: DEVICE

Changes in ERD and ERS patterns during median nerve stimulation according to the various propofol concentrations will be continuously monitored by an EEG amplifier. EEG signals will be acquired using the OpenViBE platform with a Biosemi Active Two 64-channel EEG system, arranged in the Biosemi's ABC system covering the entire scalp at 2048 Hz. Among all recorded sites, some of the electrodes will be localized around the primary motor cortex, the motor cortex, the somatosensory cortex, and the occipital cortex.

Interventions

Propofol

STIM-MOTANA is an interventional and prospective study conducted in patients scheduled for surgery under general anesthesia, involving EEG measurements and median nerve stimulation. In this study, 30 patients will undergo surgery under total intravenous anesthesia using a propofol target-controlled infusion pump. The rest of the anesthetic protocol will be at the discretion of the anesthesiologist in charge. After surgery, patients will have a gradual decrease of propofol at different effect-site concentrations (from 4.0 μg/ml to 2.0 μg/ml, in increments of 0.5 μg/ml).

Intervention Type: DRUG

Median nerve stimulation

The right-hand median nerve will be stimulated in the same way as for measurement with a conduction velocity or for an evoked potential. Two stimulation electrodes will be placed on the right-hand wrist according to the standards.The stimulation is transcutaneous and painless using the specific Micromed device Sd Ltm Stim Energy (Micromed, Mˆacon, France). The stimulus intensity will range between 3 and 14 mA. The stimulation duration will be 100 ms with a frequency of 0.1 Hz.

Intervention Type: DEVICE

EEG measurements

Changes in ERD and ERS patterns during median nerve stimulation according to the various propofol concentrations will be continuously monitored by an EEG amplifier. EEG signals will be acquired using the OpenViBE platform with a Biosemi Active Two 64-channel EEG system, arranged in the Biosemi's ABC system covering the entire scalp at 2048 Hz. Among all recorded sites, some of the electrodes will be localized around the primary motor cortex, the motor cortex, the somatosensory cortex, and the occipital cortex.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients >18 years and <81 years
• Right-handed
• Programmed for surgery with the use of an intravenous anesthesia with a propofol concentration objective

Exclusion Criteria

• Allergy to propofol, soy or peanuts
• BMI<20 or >30
• Pregnant or breastfeeding women
• Adult unable to give consent
• Medical or surgical history that may interfere with median nerve stimulation or the obtention of the EEG signal (for example: diabetes, polyneuropathy, central neurodegenerative disease, epilepsy, brain surgery)
• History of right median nerve injury
• Amputation of the upper right limb
• Impossibility of affixing an EEG helmet
• Addiction

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Brugmann University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Denis SCHMARTZ

Head of anesthesiology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denis Schmartz, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

CHU Brugmann

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Denis Schmartz, MD

Role: CONTACT

Denis.SCHMARTZ@chu-brugmann.be

3224773734

Facility Contacts

Denis Schmartz, MD

Role: primary

denis.schmartz@chu-brugmann.be

+3224773996

References

Rimbert S, Lelarge J, Guerci P, Bidgoli SJ, Meistelman C, Cheron G, Cebolla Alvarez AM, Schmartz D. Detection of Motor Cerebral Activity After Median Nerve Stimulation During General Anesthesia (STIM-MOTANA): Protocol for a Prospective Interventional Study. JMIR Res Protoc. 2023 Feb 2;12:e43870. doi: 10.2196/43870.

Reference Type: DERIVED

PMID: 36729587 (View on PubMed)

Other Identifiers

STIM-MOTANA

Identifier Type: -

Identifier Source: org_study_id